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Device-Makers Have Amped Up Defenses Against Hackers

As reports of potential cybersecurity vulnerabilities and ransomware attacks on health-care institutions have increased in recent years, manufacturers are stepping up efforts to protect their products and reputation. To defend against such attacks companies are developing strategies and hiring hackers who are able to understand potential adversaries.

Business Strategies Compliance Policy & Regulation

Behind The Scenes Of Digital Health: Medtech Players And Partners

The digitalization of health care has been much talked about over the last decade or so. But activity among the medical device manufacturers and service providers has only just recently accelerated as they start overcoming barriers and resistance to this new way of delivering health care. Unlike traditional medtech markets, digital health requires a different business model, with partnerships between device-makers and IT companies playing an integral role. This article takes an in-depth look at the players, their partnerships and products that are paving the way for a digital health future.

Digital Health Market Intelligence Commercial

Abbott Steps Up Effort To Abandon Alere Deal

Abbott has asked a Delaware court to cancel its agreement to buy Alere for $5.8bn based on a series of financial and regulatory missteps by Alere. Alere, which earlier sued to force the merger to go through, plans to fight the suit.

Commercial M & A Legal Issues

Senate Adopts Cures Bill By Big Margin; FDA Could Tap $20m More In 2017

The Senate approved the same 21st Century Cures bill passed by the House last week on a 94-5 tally; the bill is expected to be quickly signed by President Obama. Provisions for extra dollars for FDA in the bill means that even with a plan by Congress to adopt a continuing resolution this week freezing FDA funding until April 28, the agency can rely on an additional $20 million set aside for it in Cures in the new year.

Policy & Regulation Legislation United States

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The Unlikely Savior Of 21st Century Cures: Donald Trump

The 21st Century Cures bill made it through the US Congress in 2016 after all; advocates can thank the unexpected presidential victory of Donald Trump for helping to make that happen.

Legislation Policy & Regulation US Election 2016

Possible Trump FDA Commish Candidate Favors (Much) Lighter Touch

The Trump transition team is considering Jim O'Neill, a Silicon Valley investment manager, to head US FDA, according to news reports. Previous comments from O'Neill – who has some HHS experience – suggest, he favors substantially reducing FDA's role in assessing product effectiveness. While some experts are highly skeptical about O'Neill, others suggest he could champion much-needed change at the agency.

FDA Policy & Regulation US Election 2016

Latest From Policy & Regulation

Medtech Guidance Tracker: November 2016

Stay up-to-date on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. In the latest update, see documents posted in November 2016.

Policy & Regulation Medical Device

Opinion: Will EU Medtech Regs Lead You To Sell Your Home?

The EU’s medtech regulations are creating a huge and costly compliance machine. Amanda Maxwell, in the UK, comments on why you should be worried.

Europe Medical Device

New FDA Guidance Allows Easier Hearing-Aid Access

The guidance document allows patients over the age of 18 to get hearing aids without a medical evaluation. FDA also promised to work on developing a framework for over-the-counter hearing-aid sales. Both elements were included in a bill introduced in the Senate last week.

Policy & Regulation Medical Device

Interview: Where Do New Reprocessing Rules Leave EU?

Questions over proper oversight and allowances for reprocessing of single-use devices in the EU caused significant debate among policymakers who developed the pending European Medical Devices Regulation. Reprocessing advocate Dan Vukelich talked to Medtech Insight about whether or not there will be an EU-wide approach to device reprocessing under the new rules, and more about the path forward for the practice.

Europe Medical Device

Senate Panel Seeks To Ban Inpatient Concurrent Surgeries; Many Involve Devices

The Senate Finance Committee released a staff report warning about patient safety issues involved in concurrent and overlapping surgeries at inpatient hospitals – many of which involve devices – asking that CMS and other payers adopt policies to ban concurrent surgeries and better regulate overlapping ones.

Policy & Regulation United States

Regenerative Medicine Group Says Cures Act Will Help Industry

The 21st Century Cures Act will require US FDA to create standards and an expedited approval process for regenerative medicine products. Trade group ARM supports the efforts.

Policy & Regulation Legislation

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Creo Medical Braves Public Market To Score $25m IPO

Surgical endoscopy specialist Creo Medical Group plc has met its IPO target and raised £20m ($25m) ahead of its listing on the London Stock Exchange's Alternative Investment Market (AIM) on Friday 9 December.

Medical Device Gastroenterology Surgical Procedures

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Biosurfit Lands CE Mark For New Three-In-One POC HbA1c Test

IVD-maker biosurfit is seeking more distribution partners to roll out its new three-in-one POC HbA1c blood test across Europe. The IVD company secured CE-marking for the test to assist doctors diagnose and monitor diabetes.

In Vitro Diagnostics Diagnostics

Teleflex Buys Vascular Solutions For $1bn To Improve Growth

The purchase price of $56 a share in cash is a modest 16% premium over Vascular Solutions' 90-day average price. Vascular Solutions' CEO says uncertainty about the future leadership of the company compelled it to consider acquisition offers.

Commercial Companies

Patients Awarded $1bn In J&J Ultamet Hip Lawsuit

The bellwether case resulted in a jury award of $1b to a group of six California patients who say they were injured by the metal-on-metal hip. J&J plans to appeal.

Legal Issues Orthopedics

Device Week – December 2, 2016

On this week's podcast, we discussed the 21st Century Cures Act, which is headed towards likely enactment this year and includes an array of reforms to streamline the FDA process for medtech. Also, the Trump transition team’s picks for HHS and CMS. Finally, we talked about Edwards Lifesciences' recent acquisition of Valtech Cardio and key imaging industry product launches announced at this year's RSNA meeting.

Medical Device Diagnostics

VC Deals Analysis: Only Christmas Miracle Will Close Gap

As the end of the year approaches, medtech venture financing activity looks to have picked up in November to be on par with the previous year's level – but not enough to bridge the gap in annual performances.

StartUps and SMEs Financing

Start-Up Spotlight: Arterys, Allowing More To Be Seen In Cardiac MRIs

Cardiac imaging software specialist Arterys has partnered with GE Healthcare to bring to market the first easy-to-use and comprehensive MRI tool for heart defects.

Cardiology Diagnostic Imaging

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Neuronetics Launches Major Registry To Track NeuroStar TMS Outcomes

The registry will collect data from more than 6,000 depression patients treated with transcranial magnetic stimulation at more than 100 different treatment facilities in the US to better understand how the therapy benefits patients in the "real world."

Research & Development Innovation Neurology

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Cardiac Dimensions Launches IDE Trial of Carillon Mitral Repair System

The double-blind CARILLON trial will compare mechanical repair of functional mitral valve regurgitation with medical therapy alone in 400 patients at about 50 sites. The company is already running the REDUCE FMR randomized trial outside the US.

Clinical Trials Innovation

Starts & Stops: Respicardia Puts Sleep Apnea Device PAS On Snooze

Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions over the past month. This edition takes a closer look at Respicardia, which has cut short the post-approval study of its implantable sleep apnea device study.

Clinical Trials Research & Development

Device Week – December 2, 2016

On this week's podcast, we discussed the 21st Century Cures Act, which is headed towards likely enactment this year and includes an array of reforms to streamline the FDA process for medtech. Also, the Trump transition team’s picks for HHS and CMS. Finally, we talked about Edwards Lifesciences' recent acquisition of Valtech Cardio and key imaging industry product launches announced at this year's RSNA meeting.

Medical Device Diagnostics

Boston Scientific's Heart Failure Monitoring Service Shows Promise

Data from the MultiSENSE trial, presented at the American Heart Association meeting, shows Boston Scientific's planned HeartLogic alert service is able to predict impending heart failure events with 70% sensitivity and a low unexplained alert rate of 1.47 per patient per year.

Cardiology Innovation

New Data Gives Adherium Fuel To Accelerate Digital Tech Adoption in Drug Sector

With nearly 40 published peer-reviewed journal articles under its belt, Adherium is hoping that the latest clinical data which underlines the ability of the company's Smartinhaler to improve outcomes for children with poorly controlled asthma should boost the pairing of digital technologies with drugs.

Digital Health Clinical Trials

Crescendo Touts Rheumatoid Arthritis Dx Data Haul At ACR2016

Crescendo Bioscience, a wholly-owned subsidiary of Myriad Genetics, is talking-up the results of four different clinical trials of its Vectra DA multi-analyte blood test for rheumatoid arthritis that were presented at this year's American College of Rheumatology meeting in Washington, DC.

In Vitro Diagnostics Innovation